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Prospective observational study of tofacitinib in ulcerative colitis - analysis of clinical data, fatigue and health-related quality of life during the induction phase

Nyberg, Lisa LU ; Halfvarson, Jonas ; Söderling, Jonas ; Olén, Ola ; Strid, Hans ; Hedin, Charlotte R H ; Jónsdóttir, Sara B ; Hjortswang, Henrik ; Jäghult, Susanna and Cappelleri, Joseph C , et al. (2025) In Therapeutic Advances in Gastroenterology 18.
Abstract

BACKGROUND: Tofacitinib is a Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Prospective real-world data are scarce.

OBJECTIVES: To collect data on clinical outcomes, including health-related quality of life (HRQoL) and fatigue during treatment with tofacitinib.

DESIGN: This is a prospective observational multicentre study in Sweden. In this analysis, outcomes at weeks 2, 8 and 16 are reported.

METHODS: Patients with active UC confirmed with endoscopy or faecal calprotectin (FC) were enrolled during 2020-2023 when starting tofacitinib therapy.

RESULTS: In total, 103 patients were included. After 2 weeks of treatment, 50% (39/78) had achieved symptomatic response and at week 16, 39% (35/89)... (More)

BACKGROUND: Tofacitinib is a Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Prospective real-world data are scarce.

OBJECTIVES: To collect data on clinical outcomes, including health-related quality of life (HRQoL) and fatigue during treatment with tofacitinib.

DESIGN: This is a prospective observational multicentre study in Sweden. In this analysis, outcomes at weeks 2, 8 and 16 are reported.

METHODS: Patients with active UC confirmed with endoscopy or faecal calprotectin (FC) were enrolled during 2020-2023 when starting tofacitinib therapy.

RESULTS: In total, 103 patients were included. After 2 weeks of treatment, 50% (39/78) had achieved symptomatic response and at week 16, 39% (35/89) had achieved corticosteroid-free clinical remission according to the partial Mayo score. At week 16, a reduction in FC by ⩾50% was seen in 49% (35/71) and 24% (11/46) were in endoscopic remission. The frequency of arthralgia decreased from 29% (30/103) at baseline to 11% (10/89) at week 16. Regarding HRQoL at week 16; each of the four Short Health Scale dimensions (symptoms, social function, disease-related worry and general well-being) had improved by a median of 1 point (
p  < 0.01) and the European Quality of Life 5 Dimensions 5 Levels index improved from 0.80 to 0.87. Finally, the Inflammatory Bowel Disease Fatigue score measuring occurrence and severity showed an improvement with a decrease from 9 points at baseline to 6 at week 16 (
p  < 0.05).

CONCLUSION: Induction therapy with tofacitinib therapy was associated with improvements in patient-reported outcome measures of symptoms, endoscopic activity, arthralgia, HRQoL and fatigue. These real-world data illustrate that tofacitinib is a fast-acting drug with broad therapeutic effects in UC.

CLINICALTRIAL REGISTRATION NUMBER: NCT04338204.

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publication status
published
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Therapeutic Advances in Gastroenterology
volume
18
article number
17562848251343427
publisher
SAGE Publications
external identifiers
  • pmid:40535533
ISSN
1756-283X
DOI
10.1177/17562848251343427
language
English
LU publication?
yes
additional info
© The Author(s), 2025.
id
634b5bd3-815f-4082-8baa-5527e3207a53
date added to LUP
2025-06-22 10:53:19
date last changed
2025-06-23 08:28:55
@article{634b5bd3-815f-4082-8baa-5527e3207a53,
  abstract     = {{<p>BACKGROUND: Tofacitinib is a Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Prospective real-world data are scarce.</p><p>OBJECTIVES: To collect data on clinical outcomes, including health-related quality of life (HRQoL) and fatigue during treatment with tofacitinib.</p><p>DESIGN: This is a prospective observational multicentre study in Sweden. In this analysis, outcomes at weeks 2, 8 and 16 are reported.</p><p>METHODS: Patients with active UC confirmed with endoscopy or faecal calprotectin (FC) were enrolled during 2020-2023 when starting tofacitinib therapy.</p><p>RESULTS: In total, 103 patients were included. After 2 weeks of treatment, 50% (39/78) had achieved symptomatic response and at week 16, 39% (35/89) had achieved corticosteroid-free clinical remission according to the partial Mayo score. At week 16, a reduction in FC by ⩾50% was seen in 49% (35/71) and 24% (11/46) were in endoscopic remission. The frequency of arthralgia decreased from 29% (30/103) at baseline to 11% (10/89) at week 16. Regarding HRQoL at week 16; each of the four Short Health Scale dimensions (symptoms, social function, disease-related worry and general well-being) had improved by a median of 1 point (<br>
 p  &lt; 0.01) and the European Quality of Life 5 Dimensions 5 Levels index improved from 0.80 to 0.87. Finally, the Inflammatory Bowel Disease Fatigue score measuring occurrence and severity showed an improvement with a decrease from 9 points at baseline to 6 at week 16 ( <br>
 p  &lt; 0.05).<br>
 </p><p>CONCLUSION: Induction therapy with tofacitinib therapy was associated with improvements in patient-reported outcome measures of symptoms, endoscopic activity, arthralgia, HRQoL and fatigue. These real-world data illustrate that tofacitinib is a fast-acting drug with broad therapeutic effects in UC.</p><p>CLINICALTRIAL REGISTRATION NUMBER: NCT04338204.</p>}},
  author       = {{Nyberg, Lisa and Halfvarson, Jonas and Söderling, Jonas and Olén, Ola and Strid, Hans and Hedin, Charlotte R H and Jónsdóttir, Sara B and Hjortswang, Henrik and Jäghult, Susanna and Cappelleri, Joseph C and Henrohn, Dan and Seddighzadeh, Maria and Marsal, Jan and Grip, Olof}},
  issn         = {{1756-283X}},
  language     = {{eng}},
  publisher    = {{SAGE Publications}},
  series       = {{Therapeutic Advances in Gastroenterology}},
  title        = {{Prospective observational study of tofacitinib in ulcerative colitis - analysis of clinical data, fatigue and health-related quality of life during the induction phase}},
  url          = {{http://dx.doi.org/10.1177/17562848251343427}},
  doi          = {{10.1177/17562848251343427}},
  volume       = {{18}},
  year         = {{2025}},
}